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Bupropion hydrochloride slow release tablets and preparation method thereof

A technology of bupropion hydrochloride and sustained-release tablets, which is applied in the direction of non-active ingredients of medical preparations, pharmaceutical formulas, oil/fat/wax non-active ingredients, etc., can solve the problems of increased incidence of epilepsy, environmental pollution, tablet Faster release and other issues, to achieve good stability of related substances, reduce clinical risk, and good release stability

Active Publication Date: 2020-09-11
DISHA PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the addition of acidic environment regulators has brought about environmental pollution, corrosion of equipment and molds, etc.
At the same time, because hypromellose, a sustained-release material in the prescription, is unstable under acidic conditions, the tablets produced tend to release faster during storage, which may cause clinically significant changes in the incidence of epilepsy. improve

Method used

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  • Bupropion hydrochloride slow release tablets and preparation method thereof
  • Bupropion hydrochloride slow release tablets and preparation method thereof
  • Bupropion hydrochloride slow release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1 Preparation of Bupropion Hydrochloride Sustained Release Tablets

[0032] Step 1. Preparation of Bupropion Hydrochloride Solid Dispersion

[0033] Prescription: bupropion hydrochloride 150g, carnauba wax 100g, deionized water 600g

[0034] The preparation method is as follows:

[0035] (1) Melt the prescribed amount of carnauba wax in a water bath at 90°C and set aside.

[0036] (2) Take the prescribed amount of bupropion hydrochloride plus deionized water to dissolve completely, raise the temperature to 90°C, add it to the molten waxy phase, stir evenly in a water bath at 90°C, spread the mixture on the tray, Vacuum drying at 90°C for 0.5-2 hours under reduced pressure, and the dried dispersion was passed through a 40-mesh sieve and pulverized to obtain a solid dispersion of bupropion hydrochloride.

[0037] Step 2 Preparation of Bupropion Hydrochloride Sustained Release Tablets

[0038] Prescription: 220g of bupropion hydrochloride solid dispersion obtai...

Embodiment 2

[0063] Example 2 Preparation of Bupropion Hydrochloride Sustained Release Tablets

[0064] Step 1. Preparation of Bupropion Hydrochloride Solid Dispersion

[0065] Prescription: bupropion hydrochloride 150g, carnauba wax 40g, deionized water 600g

[0066] The preparation method is as follows:

[0067] (1) Melt the carnauba wax in a water bath at 90°C and set aside.

[0068] (2) Take bupropion hydrochloride and deionized water to dissolve completely, raise the temperature to 90°C, add to the molten waxy phase, stir evenly in a water bath at 90°C, spread the mixture on a tray, and heat it at 90°C Vacuum drying under reduced pressure for 0.5 to 2 hours, and the dried dispersion was passed through a 40-mesh sieve and pulverized to obtain a solid dispersion of bupropion hydrochloride.

[0069] Step 2 Preparation of Bupropion Hydrochloride Sustained Release Tablets

[0070] Prescription: 190g of bupropion hydrochloride solid dispersion obtained in step 1, 146g of microcrystallin...

Embodiment 3

[0076] Example 3 Preparation of Bupropion Hydrochloride Sustained Release Tablets

[0077] Step 1. Preparation of Bupropion Hydrochloride Solid Dispersion

[0078] Prescription: bupropion hydrochloride 150g, carnauba wax 70g, deionized water 600g

[0079] The preparation method is as follows:

[0080] (1) Melt the carnauba wax in a water bath at 90°C and set aside.

[0081] (2) Take bupropion hydrochloride and deionized water to dissolve completely, raise the temperature to 90°C, add to the molten waxy phase, stir evenly in a water bath at 90°C, spread the mixture on a tray, and heat it at 90°C Vacuum drying under reduced pressure for 0.5 to 2 hours, and the dried dispersion was passed through a 40-mesh sieve and pulverized to obtain a solid dispersion of bupropion hydrochloride.

[0082] Step 2 Preparation of Bupropion Hydrochloride Sustained Release Tablets

[0083] Prescription: 250g of bupropion hydrochloride solid dispersion obtained in step 1, 22g of microcrystalline...

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Abstract

The invention relates to bupropion hydrochloride slow release tablets. Every 1000 pieces of the bupropion hydrochloride slow release tablets contain 150g of bupropion hydrochloride, 40-100g of carnauba wax, 40-160g of hydroxypropyl methylcellulose E4M, 16-40g of Macrogol 4000, 20-160g of microcrystalline cellulose and 4-12g of magnesium stearate, wherein the bupropion hydrochloride exists in the form of dispersoid. The invention provides the stable, safe and environment-friendly bupropion hydrochloride slow release tablets and a preparation method.

Description

technical field [0001] The invention relates to a bupropion hydrochloride sustained-release tablet, in particular to a preparation method of the bupropion hydrochloride sustained-release tablet, and belongs to the field of pharmaceutical preparations. Background technique [0002] Bupropion hydrochloride is a blocker of nerve uptake of serotonin and non-catechol, which inhibits the reuptake of dopamine by nerves to a certain extent, and is clinically used for the treatment of depression. Relevant clinical studies have shown that the onset of epilepsy, the adverse reaction of bupropion hydrochloride, is related to its unsteady release. When the daily dose of the immediate-release preparation is 450mg, the incidence rate can reach 0.4%. The use of sustained-release preparations of bupropion hydrochloride can slowly release the drug, avoiding the peak-valley phenomenon of blood drug concentration, thereby reducing the incidence rate and reducing the number of medications. Can ...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/22A61K47/44A61K47/10A61K47/38A61K31/137A61P25/24
CPCA61K9/2013A61K9/2031A61K9/2054A61K9/28A61K31/137A61P25/24
Inventor 周祥彪杨德斌李洋都书晓姜雅萌
Owner DISHA PHARMA GRP
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